(76 days)
The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery.
The Glidesheath Slender consists of an introducer sheath and a dilator which are packaged together with an entry needle and mini guide wire. The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery. The sheath and dilator contain bismuth. making these devices visible under fluoroscopy. The sheath is coated with hydrophilic coating to minimize frictional resistance when inserting or removing the sheath from the patient's blood vessel.
The entry needle (cannula) is used to gain access to the radial artery for placement of the mini guide wire. The entry needle is offered in two versions, either a stainless steel needle or a Surflo IV catheter (K891087).
The mini guide wire is used for placement of the sheath and dilator into the radial artery. The mini guide wire is offered in two versions, either a stainless steel (spring coil) model or a polyurethane (nitinol core) plastic model.
A guide wire inserter is also provided to assist in insertion of the mini guide wire into the cannula.
The provided 510(k) summary describes the Glidesheath Slender, a catheter introducer. This document focuses on demonstrating substantial equivalence to a predicate device (Terumo Glidesheath K082644) through performance testing, material comparison, and biocompatibility evaluations, rather than reporting on a study measuring a specific clinical outcome with defined acceptance criteria for device performance.
Therefore, many of the requested sections related to acceptance criteria, device performance, expert-established ground truth, MRMC studies, standalone performance, and training/test set details are not applicable as this is a submission for a medical device that relies on bench testing and material equivalency, not an AI/software as a medical device (SaMD).
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria or quantifiable device performance results for clinical outcomes. Instead, it lists various performance tests conducted according to ISO standards and internal standards to verify substantial equivalence to the predicate device. The implied acceptance criterion for each test is that the Glidesheath Slender performs adequately and comparably to the predicate device, thereby ensuring safety and effectiveness.
Table of Performance Tests and General Outcome (as inferred from the document):
| Performance Testing (Sheath) | Method | Implied Acceptance Criteria / Outcome |
|---|---|---|
| Surface | ISO 11070 Sec. 4.3 | Conforms to visual/tactile inspection; comparable to predicate. |
| Corrosion resistance | ISO 11070 Sec. 4.4 | Resistant to corrosion; comparable to predicate. |
| Radiodetectability | ISO 11070 Sec. 4.5 | Visible under fluoroscopy; comparable to predicate. |
| Dimensional verification | ISO 11070 Sec. 7.2 | Dimensions within specified tolerances; comparable to predicate. |
| Freedom from leakage (sheath) | ISO 11070 Sec. 7.3 | No leakage; comparable to predicate. |
| Freedom from leakage (hemostasis valve) | ISO 11070 Sec. 7.4 | No leakage; comparable to predicate. |
| Force at break (sheath) | ISO 11070 Sec. 7.6 | Meets strength requirements; comparable to predicate. |
| Force at break (sheath to hub) | ISO 11070 Sec. 7.6 | Meets strength requirements; comparable to predicate. |
| Sheath to dilator fit | ISO 11070 Sec. A.1 | Proper fit; comparable to predicate. |
| Rollback test | ISO 11070 Sec. A.1 | Demonstrates adequate coating adhesion/stability; comparable to predicate. |
| Puncture model test | ISO 11070 Sec. A.1 | Demonstrates appropriate performance upon insertion; comparable to predicate. |
| Flexibility (kink angle) | ISO 11070 Sec. A.1 | Meets flexibility requirements; comparable to predicate. |
| Flexibility (radius of curvature) | ISO 11070 Sec. A.1 | Meets flexibility requirements; comparable to predicate. |
| Catheter insertion resistance | Internal Standard | Low resistance comparable to predicate. |
| Penetration resistance | Internal Standard | Appropriate resistance; comparable to predicate. |
| External surface sliding performance | Internal Standard | Smooth sliding; comparable to predicate. |
| Hydrophilic coating separation resistance | Internal Standard | Coating remains intact; comparable to predicate. |
| Hydrophilic coating particulate evaluation | FDA Guidance, USP788 | Meets particulate limits; comparable to predicate. |
| Performance Testing (Dilator) | ||
| Surface | ISO 11070 Sec. 4.3 | Conforms to visual/tactile inspection; comparable to predicate. |
| Corrosion resistance | ISO 11070 Sec. 4.4 | Resistant to corrosion; comparable to predicate. |
| Dimensional verification | ISO 11070 Sec. 9.2 | Dimensions within specified tolerances; comparable to predicate. |
| Conical fitting | ISO 11070 Sec. 9.3.2, ISO 594-1 | Proper conical fit; comparable to predicate. |
| Strength of union (dilator to hub) | ISO 11070 Sec. 9.3.3 | Meets strength requirements; comparable to predicate. |
| Performance Testing (Stainless Steel Needle) | ||
| Surface | ISO 11070 Sec. 4.3 | Conforms to visual/tactile inspection; comparable to predicate. |
| Corrosion resistance | ISO 11070 Sec. 4.4 | Resistant to corrosion; comparable to predicate. |
| Radiodetectability | ISO 11070 Sec. 4.5 | Visible under fluoroscopy; comparable to predicate. |
| Dimensional verification | ISO 11070 Sec. 5.2 | Dimensions within specified tolerances; comparable to predicate. |
| Needle point | ISO 11070 Sec. 5.3 | Sharp and properly formed; comparable to predicate. |
| Conical fitting | ISO 11070 Sec. 5.4.1, ISO 594-1 | Proper conical fit; comparable to predicate. |
| Strength of union (needle tube to hub) | ISO 11070 Sec. 5.4.2 | Meets strength requirements; comparable to predicate. |
| Performance Testing (Surflo IV Needle) | ||
| Surface | ISO 11070 Sec. 4.3 | Conforms to visual/tactile inspection; comparable to predicate. |
| Corrosion resistance | ISO 11070 Sec. 4.4 | Resistant to corrosion; comparable to predicate. |
| Radiodetectability | ISO 11070 Sec. 4.5 | Visible under fluoroscopy; comparable to predicate. |
| Dimensional verification | ISO 11070 Sec. 5.2 | Dimensions within specified tolerances; comparable to predicate. |
| Needle point | ISO 11070 Sec. 5.3 | Sharp and properly formed; comparable to predicate. |
| Conical fitting | ISO 11070 Sec. 5.4.1, ISO 594-1 | Proper conical fit; comparable to predicate. |
| Strength of union (needle tube to hub) | ISO 11070 Sec. 5.4.2 | Meets strength requirements; comparable to predicate. |
| Performance Testing (Surflo IV Catheter) | ||
| Surface | ISO 11070 Sec. 4.3 | Conforms to visual/tactile inspection; comparable to predicate. |
| Corrosion resistance | ISO 11070 Sec. 4.4 | Resistant to corrosion; comparable to predicate. |
| Radiodetectability | ISO 11070 Sec. 4.5 | Visible under fluoroscopy; comparable to predicate. |
| Catheter to needle fit | ISO 11070 Sec. 6.2 | Proper fit; comparable to predicate. |
| Strength of union (catheter to hub) | ISO 11070 Sec. 6.3 | Meets strength requirements; comparable to predicate. |
| Conical fitting | ISO 11070 Sec. 6.4, ISO 594-1 | Proper conical fit; comparable to predicate. |
| Dimensional verification | ISO 11070 Sec. 6.5 | Dimensions within specified tolerances; comparable to predicate. |
| Performance Testing (Plastic Guide Wire) | ||
| Surface | ISO 11070 Sec. 4.3 | Conforms to visual/tactile inspection; comparable to predicate. |
| Radiodetectability | ISO 11070 Sec. 4.5 | Visible under fluoroscopy; comparable to predicate. |
| Dimensional verification | ISO 11070 Sec. 8.2 | Dimensions within specified tolerances; comparable to predicate. |
| Test for fracture of guide wire | ISO 11070 Sec. 8.4 | Resistant to fracture; comparable to predicate. |
| Resistance to damage by flexing | ISO 11070 Sec. 8.5 | Resistant to damage from flexing; comparable to predicate. |
| Performance Testing (Stainless Steel Guide Wire) | ||
| Surface | ISO 11070 Sec. 4.3 | Conforms to visual/tactile inspection; comparable to predicate. |
| Corrosion resistance | ISO 11070 Sec. 4.4 | Resistant to corrosion; comparable to predicate. |
| Radiodetectability | ISO 11070 Sec. 4.5 | Visible under fluoroscopy; comparable to predicate. |
| Dimensional verification | ISO 11070 Sec. 8.2 | Dimensions within specified tolerances; comparable to predicate. |
| Test for fracture of guide wire | ISO 11070 Sec. 8.4 | Resistant to fracture; comparable to predicate. |
| Resistance to damage by flexing | ISO 11070 Sec. 8.5 | Resistant to damage from flexing; comparable to predicate. |
| Strength of union of safety wire and coil | ISO 11070 Sec. 8.6 | Meets strength requirements; comparable to predicate. |
| Strength of union of core wire and coil | ISO 11070 Sec. 8.7 | Meets strength requirements; comparable to predicate. |
| Biocompatibility | ISO 10993-1:2009 | Classified as Externally Communicating Devices, Circulating Blood, Limited Contact ( Bacterial Endotoxins Test, FDA Guideline (1987) |
| TiO2 Particle Release | ISO10993-12 | Potential release much lower than tolerable intake (NOAEL); no safety concern. |
The "reported device performance" is implicitly that the device successfully met all these technical and biological safety requirements, thereby demonstrating substantial equivalence to the predicate device.
2. Sample size(s) used for the test set and the data provenance
The document refers to "bench tests" and "each lot of production" for LAL tests. It does not specify a distinct "test set" in the context of patient data. The tests are focused on component and assembly performance, material properties, and sterilization, typically involving a representative number of units or material samples from manufacturing lots. No patient data or clinical data is mentioned for these performance tests.
- Test Set Sample Size: Not specified in the context of patient data; applies to manufactured units/samples for bench testing.
- Data Provenance: Not applicable as these are bench tests and laboratory evaluations, not data from a specific country of origin or retrospective/prospective patient studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device's evaluation relies on established engineering standards, biocompatibility protocols, and manufacturing quality controls, not an expert consensus on a "ground truth" derived from patient cases.
4. Adjudication method for the test set
Not applicable. No expert adjudication process is described for these types of performance tests.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/SaMD device, and therefore, an MRMC study is not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/SaMD device.
7. The type of ground truth used
The "ground truth" for this device's evaluation is defined by established engineering specifications, material composition standards, ISO/FDA recognized test methods, and biocompatibility requirements. For instance, the ground truth for "Dimensional verification" is the specified blueprint dimensions, and for "Corrosion resistance," it's the absence of corrosion under specified conditions.
8. The sample size for the training set
Not applicable. This is not an AI/SaMD device; there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no "training set" or corresponding ground truth.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).